510(k) · Cleared
ClearedCORA (Coagulation Resonance Analysis) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coramed Technologies, LLC · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Jun 26, 2015 as substantially equivalent to K002177 (Haemoscope Corp., 2000) after a 168-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Jun 26, 2015
- Review
- 168 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002177 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000 · Recalled
- This deviceK150041 CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 2015
- Descendant · cites it directly · 1 of its ownK243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK251024 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics · 2025
- Descendant · cites it directly · 0 of its ownK232018 Citrated: K, KH, RTH, FFHHaemonetics Corporation · 2024
- Descendant · cites it directly · 0 of its ownK160502 TEG 6s Hemostasis SystemHaemonetics Corporation · 2017
Most influential descendants
Showing 4 of 4 · See all- K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025 · cites it directly1descendant
- K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics · 2025 · 2 generations on0descendants
- K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation · 2024 · cites it directly0descendants
- K160502TEG 6s Hemostasis SystemHaemonetics Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | 7 |
| 0 (this device) | K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | 2015 | — |
| +1 | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | 2025 | — |
| +2 | K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | 2025 | — |
| +1 | K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | 2024 | — |
| +1 | K160502 | TEG 6s Hemostasis System | Haemonetics Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 SeriesSummary page 6…n Name: 21CFR 864.5425 Multipurpose System for in vitro Coagulation Studies PREDICATE DEVICE o Thrombelastograph® Coagulation Analyzer (TEG®) – 5000 Series, K002177, Product Code JPA (System, Multipurpose, for In Vitro Coagulation Studies), Haemoscope Corporation ===… | 2000 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The CORA System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents…
Read the full statement (162 words)
The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The CORA System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV.
The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges.
Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests.
The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150041: CORA (Coagulation Resonance Analysis) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026